Here’s a concise and well-organized rewrite of the job summary for clarity and engagement:
Quality Operations Specialist
Location: Hyderabad, India
About Novartis:
At Novartis, we strive to improve lives through innovative science, collaboration, and a commitment to quality. Join our team and help create a brighter future for patients worldwide.
About the Role:
As a Quality Operations Specialist, you will deliver quality services that ensure compliance with cGMP standards and the Novartis Quality Management System. Your role will support key quality activities across product compliance, regulatory workflows, and operational excellence.
Key Responsibilities:
Provide quality operations services for product compliance, including workflows in applications like SAP, Dragon, and SUBWAY.
Support stability management tasks such as temperature excursion assessments (TEA) and transport risk assessments (TRA).
Assist QC release activities, including creating and reviewing Inspection Plans, Lot Numbers, Certificates of Analysis, and Compliance.
Develop and manage testing monographs and perform impact assessments.
Author risk evaluation reports for nitrosamines (Step-1 & Step-2) and manage associated activities in Subway software.
Perform statistical analysis, performance trending, and provide business support.
Ensure compliance with Novartis quality standards, regulatory requirements, and service level agreements.
Support internal and external audits while adhering to GxP and compliance policies.
Key Performance Indicators:
On-time and GMP-compliant release of products.
Effective handling of inspections with no adverse findings.
Successful participation in continuous improvement initiatives.
Minimum Requirements:
Education: Pharmacy, Science, MBA, Engineering, or equivalent from a recognized institute.
Experience: Minimum 3 years in Quality Assurance, Regulatory, or pharmaceutical manufacturing.
Skills: GxP knowledge, basic IT expertise, excellent communication and interpersonal skills, experience working with global stakeholders.
Languages: Fluent in English (written and spoken).
Desirable Skills:
Continuous learning mindset.
Knowledge of GMP procedures and QA/QC testing.
Technological expertise and adaptability.
Why Novartis:
We believe improving lives requires more than science—it takes a passionate community working together to inspire breakthroughs. Be part of a team that values inclusion, diversity, and innovation.
Accessibility and Accommodation:
Novartis is committed to providing reasonable accommodations for individuals with disabilities. For support, email diversityandincl.india@novartis.com, including the job requisition number.
Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full-Time, Regular
Join the Novartis Talent Network to explore opportunities and grow your career with us.
Let me know if you’d like further adjustments!
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
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Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Netanya | Be'Er Sheva | Tel Aviv | Kfar Saba | Yavne |Remote :
Lenexa | Springville | Thailand | Xzagreb | Ireland | McFarland | French | Minnesota | Bountiful | Remote - Africa | Riga | Melbourne | Remote | Belgium | Leinster | Hammond | Regulatory Labeling Manager (NA and LATAM Only) | Remote - South America (Latin Americal) | Tulsa | Remote - Europe | Medan | Slovakia | Hungary | Texas | Remote - Middle East | Remote, USA | Lousiana | Manipal | Faridabad | Blue Bell | Castlebar | Victoria | Zaragoza | Bishop | Switzerland | Nairobi | Green Way |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
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